United States: Hatch-Waxman Act Certification Sufficiency of Notice for Paragraph IV Certification Still in Limbo

Noting the complexity of the Hatch-Waxman Act (H-W) statutory scheme, the U.S. Court of Appeals for the Federal Circuit upheld a dismissal, with prejudice, of a patent suit filed against a U.S. Food and Drug Administration (FDA) applicant who had certified under the H-W that its generic drug did not infringe the patent in question. Minnesota Mining and Mfg. Co. v. Barr Laboratories, Inc., Case Nos. 01-1369, -1370 (Fed. Cir., May 1, 2002).

This case involves the interaction between the 180-day waiting period under the H-W, 21 U.S.C. § 355(j)(5)(B)(iv)(II), for a second manufacturer of a generic drug and the sufficiency of notice of no patent infringement under "the paragraph IV certification" procedure.

3M is the manufacturer of Tambocor® and the owner of a patent claiming intermediate compounds in the drug’s manufacture. Tambocor® (flecainide acetate) is used in the treatment of heart rhythm disturbances. As required by the H-W, 3M’s patent is listed in the FDA’s so-called Orange Book. Alphapharm, the first appellant to file with the FDA for approval to market a generic form of flecainide, is not currently marketing the drug.

Barr was the second manufacturer to file with the FDA for approval to market a generic form of flecainide. As required by the H-W, Barr filed a paragraph IV certification simply stating that its formulation did not infringe the listed 3M patent. After 3M sued Barr for patent infringement, it discovered that, in fact, Barr’s formulation did not infringe the patent. 3M requested that the district court dismiss the suit without prejudice, alleging that Barr had "hoodwinked" 3M into bringing suit by failing to provide 3M with sufficient notice through a more "detailed statement" in its paragraph IV certification. The district court, however, dismissed the suit with prejudice, finding "no impropriety in Barr’s declining to provide further information." The district court found that 3M was merely attempting to avoid an adverse judgment in the district court proceeding" to avoid triggering the 180-day period (under H-W §355(j)(5)(B)(iv)(II)) after which Barr could bring its drug to market.

The Federal Circuit, in affirming the dismissal with prejudice, noted that neither the district court, nor any other court, had the authority to determine the sufficiency of notice in a paragraph IV certification. Following its recent decisions in Mylan v. Thompson and Andrx v. Biovail, the Federal Circuit held that matters affecting listing of a patent in the Orange Book cannot be enforced by a private party in a patent infringement action but rather must "be enforced, if at all, in the context of an action under the Administrative Procedure Act (APA)" at the FDA.

In a concurring opinion, Judge Gajarsa explained that the "majority fails to address the key issues in this appeal and adds an entire layer of administrative complexity to create a sizeable procedural Gordian knot." Per Judge Gajarsa, generic drug companies "who clearly do not infringe" should not have to "survive administrative challenge to their paragraph IV certification notice before they can obtain a favorable judgment" and trigger the 180-day period. The concurring opinion also quotes the FDA as stating that it "lacks expertise in patent law" and "is neither prepared nor required to become involved in issues concerning sufficiency of notice for purposes of enforcing patent law."